Flucelvax (TIVc or QIVc) Pregnancy Registry

NCT03438487 | Completed DMC FDA Drug

• 1 other identifier: V130_11OB
• Study Type: observational
• Target: 692
• Locations: 1 country
• Sites: 1

Brief Summary

The study is a population based prospective cohort study designed to collect data on pregnancy outcomes and events of interest among women immunized with the TIVc or QIVc vaccine during pregnancy.

Conditions

Influenza, Human; Pregnancy; Birth Defect

Outcome Measures

Primary Outcomes (4)

• Safety Objective: Number of cases for pregnancy outcomes among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.

  Number of cases for pregnancy outcomes will be reported as one of the following: live birth, stillbirth, spontaneous abortion and elective termination

  From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks

• Safety Objective: Number of cases with major congenital malformations among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.

  From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks

• Safety Objective: Number of cases with events of preterm birth among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.

  From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks

• Safety Objective: Number of cases with low birth weight among women immunized as part of routine care with the seasonal cell culture influenza trivalent (TIVc) or quadrivalent (QIVc) vaccine during pregnancy.

  From time of enrollment during pregnancy to time of delivery or pregnancy termination; a follow-up period of up to 40 weeks

Study Arms (1)

Flucelvax Trivalent or Quadrivalent Influenza Vaccine

Flucelvax Trivalent or Quadrivalent exposure in pregnancy

Biological: Flucelvax Trivalent Influenza Vaccine; Biological: Flucelvax Quadrivalent Influenza Vaccine

Interventions

Flucelvax Trivalent Influenza Vaccine BIOLOGICAL

Flucelvax is a cell culture seasonal trivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage or B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol)

Also known as: Flucelvax

Flucelvax Trivalent or Quadrivalent Influenza Vaccine

Flucelvax Quadrivalent Influenza Vaccine BIOLOGICAL

Flucelvax Quadrivalent is a cell culture seasonal quadrivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage, 4) B/Victoria lineage Vaccine exposure in routine care (no vaccination per protocol)

Also known as: Flucelvax Quadrivalent

Flucelvax Trivalent or Quadrivalent Influenza Vaccine

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include pregnant women within the US who were immunized with the TIVc or the QIVc vaccine as part of routine care at any time during pregnancy. Eligible pregnant women may self-enroll or voluntarily be enrolled by their HCP. Women under 18 can be included in the study as long as parental consent can be obtained. De-identified data on minors will be accepted into the study if permitted by laws and regulations.

You may qualify if:

• Enrollment and data collection will be coordinated through a coordination center (CC). The minimum eligibility criteria required for enrollment are as follows:
• Sufficient information to confirm that the exposure of interest occurred during pregnancy and at which date.
• Sufficient information to determine whether it concerns a prospectively enrolled subject, since retrospective cases are ineligible for enrollment.
• Reporter (e.g. HCP) contact information to allow for follow-up

You may not qualify if:

• N/A

Sponsors & Collaborators

• Seqirus: lead

Study Sites (1)

Syneos Health

Wilmington, North Carolina, 28405, United States

Location

MeSH Terms

Conditions

Influenza, Human; Congenital Abnormalities

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Head Epidemiology

  Seqirus

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: February 19, 2018
• Study Start: September 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

US (1)